Single Dose Study of PF-05230907 in Healthy Japanese Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

The purpose of this study is the following: * To determine the safety and tolerability of single ascending intravenous (IV) doses of PF-05230907 in healthy Japanese subjects. * To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy Japanese subjects. * To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy Japanese subjects. * To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects

Key facts

Study ID

NCT02537002

Run by

Pfizer

People needed

17

Starts

2015-09-01

Expected to finish

2016-03-01

Last updated by the study team

2016-04-29

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male of females
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and <120 kg (265 lbs).
• Japanese subjects who have four biologic Japanese grandparents born in Japan.

You may not qualify if…

• Pregnant or nursing females.
• Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease

Where it is running

• Pfizer New Haven Clinical Research Unit — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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